Skip to content

Two Monitors for Measuring the Activated Clotting Time: A Comparison

Comparison of Two Point of Care Techniques Mechanical Versus Biochemical Activated Clotting Time

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03203148
Enrollment
20
Registered
2017-06-29
Start date
2017-04-18
Completion date
2017-11-01
Last updated
2023-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Coagulation, Cardiopulmonary Bypass, Point-of-Care Testing

Keywords

Cardiopulmonary Bypass, Blood Coagulation Testing, Point-of-Care Testing

Brief summary

In this observational study a comparison is made between two different monitors for measurement of the activated clotting time (ACT): mechanical versus biochemical techniques

Detailed description

The ACT is a functional test influenced by multiple factors, such as platelet function, coagulation factors, temperature and contact activation inhibitors. Results produced by different monitors are also prone to vary influenced by the specific method employed to perform the test. The present clinical study aims to compare two types of ACT monitors: the Hemostatic Management System Plus (Medtronic) and i-STAT (Abbott) in 20 cardiac surgical patients by performing five intraoperative consecutive measurements using anti factor Xa as a reference for the actual heparin concentration. Inclusion criteria comprised patients aged 20-80 years, scheduled for coronary bypass surgery. Measurements: 1) before induction of anaesthesia 2 ) after heparin bolus 3) rewarming of the patient 4) weaning from cardiopulmonary bypass 5) after protamine administration. The Hemostatic System Plus ACT monitor served as reference for dosing of heparin in all patients. The study protocol did not intervene with the standard protocol used for anticoagulation. No patient interventions were made. It is hypothesised that the i-STAT ACT monitor has a better correlation with the actual heparin concentration than the Hemostatic Management System Plus

Interventions

DIAGNOSTIC_TESTPoint-of-Care ACT

Comparison between two point-of-care devices for measurement of the activated clotting time

Sponsors

Umeå University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Patients listed for coronary bypass surgery, -

Exclusion criteria

Primary coagulation disorder, diabetes mellitus, ongoing anti-coagulation therapy, emergency, reduced kidney function, allergy for fish, sea food and protamine \-

Design outcomes

Primary

MeasureTime frameDescription
Activated Clotting timeIntraoperativeCoagulation Measure

Secondary

MeasureTime frameDescription
Anti-Factor XaIntraoperativeReference for heparin plasma concentration

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026